ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000905561

Ethics application status

Approved

Date submitted

7/08/2015

Date registered

1/09/2015

Date last updated

23/08/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

The impact of the Dementia Care in Hospitals Program in improving the quality of life and adverse events in acute hospital patients with cognitive impairment: A stepped wedge cluster trial

Scientific title

Efficacy of an all of hospital staff, education and awareness program for cognitive impairment called the Dementia Care in Hospital Program versus usual care on quality of life and incidence rate of hospital acquired adverse events in acute hospital inpatients with cognitive impairment.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1172-9955

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hospital aquired adverse events

Cognitive Impairment

Delirium

Dementia

Condition category

Condition code

Neurological

Dementias

Injuries and Accidents

Other injuries and accidents

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The effect of the DCHP will be measured in four different hospitals in Australia. The starting time for site 2,3 and 4 will be at 3 months intervals after site 1. Each site will have a 10week control period ( baseline data), a 4 week implementation period (no data collection) before a 12 month intervention period. The results will be pooled for final reporting.

The education component of the intervention is a face to face 15-30 min power-point provided by nurse educators to clinical and non-clinical staff focussing on good communication, re-orientation and carer engagement. The education will occur in the 3 months prior to implementation and continue throughout the interventation period for new staff to the target wards. The education is provided to all levels of clinical and non-clinical staff who may have contact with a pateint with Cognitive Impairment (CI).An education register is kept and it is expected that 80% of staff will be educated. Each hospital has selected between 5 -7 wards in their acute service. Intensive Care, Emergency and Peadiatrics are excluded.The awareness component is the use of an over bedside graphic called the Cognitive Impairment Identifier linked to positive screening for CI. The CII is copyrighted to Ballarat Health Service.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

Usual acute hospital care. This is care as required for hospital accreditation.Currently this is usually care targetting patients with CI who are percieved as disruptive on the ward. In such cirmcustances the patient may be "specialled" ( have additional 1 on 1 staff supervision) and the family asked to stay.

Control group

Active

Outcomes

Primary outcome [1]

Frequency of nursing modifiable hospital aquired adverse, specifically pressure areas, pneumonia, delirium and urinary tract infections in patients aged 65 years and over identified with cognitive impairment.
The adverse event data will be collected using the existing hospital adverse event reporting systems. Health Round Table will collate the hospital data reporting on-
1. All patients admitted for multi-day stay aged 65 years and over (aged 50 years and over for ATSI status patients)
2. For all patients admitted for multi-day stay aged 65 years and over (aged 50 years and over for ATSI status patients):
a) Gender
b) Severity Index (Charlson Co-Morbidity excluding dementia)
c) Surgical Status
d) Adverse Events

Timepoint [1]

At 3, 6, 9 and 12 months post the implementation period.

Secondary outcome [1]

Change in patient quality of Life as measured by the DEMQoL

Timepoint [1]

6 and 12 months post the implementation period.

Secondary outcome [2]

Change staff knowledge about cognitive impairment and in staff perception of competence and of bother caring for patients with CI using a single study specific questionnaire.

Timepoint [2]

6 and 12 months post inplementation.

Secondary outcome [3]

Change in carer satisfaction using a study specific questionnaire.

Timepoint [3]

6 and 12 months post inplementation.

Secondary outcome [4]

Implementation cost and cost effectivness.
The primary economic evaluation will comprise a cost minimisation exercise. An analysis of costs and quality-of-life will also be undertaken to determine the ICER as the ratio of the mean cost difference between patients (aged 65+ with CI) in the pre- and post-implementation periods to the mean difference in DEMQOL score between patients (aged 65+ with CI) in the pre- and post-implementation period.

Timepoint [4]

End of study

Eligibility

Key inclusion criteria

Cognitive impairment using a validated screening tool ( eg AMTS, mini-COG, AMT4, AT4). The tool used will be determined by the hospital.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Too unwell to complete the CI screening test and declines to participate in the DCHP. A consent waiver has been given for the collection of the adverse event data.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The choice as to which site went first was based on site organisational readiness. The wards are chosen by the site to include wards representative the inpatients group.All patients who meet all the inclusion criteria and none of the exclusion criteria will be included.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

21/07/2015

Date of last participant enrolment

Anticipated

14/02/2017

Actual

Date of last data collection

Anticipated

14/05/2017

Actual

Sample size

Target

15000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,SA,TAS,WA

Recruitment hospital [1]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [2]

The Canberra Hospital - Garran

Recruitment hospital [3]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [4]

Royal Hobart Hospital - Hobart

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health, Australian Government

Address [1]

Tuggeranong Office Park
Soward Way (cnr Athllon Drive)
Greenway ACT 2900

PO Box 7576
Canberra Business Centre ACT 2610

Country [1]

Australia

Primary sponsor type

Government body

Name

Ballarat Health Services

Address

Drummond Street North
Ballarat 3350
Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ballarat and St John Of God HREC

Ethics committee address [1]

1 Dummond Street North

Ballarat Central, Vic 3350

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/05/2015

Approval date [1]

07/05/2015

Ethics approval number [1]

HREC/15/BHSSJOG/13

Ethics committee name [2]

Human Research Ethics Committee (TQEH/LMH/MH)

Ethics committee address [2]

Basil Hetzel Institute DX465101
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

15/03/2015

Approval date [2]

05/06/2015

Ethics approval number [2]

HREC/15/TQEH/9

Ethics committee name [3]

Sir Charles Gairdner Group Human Research Ethics Committee (EC00271)

Ethics committee address [3]

Sir Charles Gairdner Hospita
Hospital Avel 
Nedlands
6009
WA

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

26/06/2015

Approval date [3]

26/10/2015

Ethics approval number [3]

2015-103

Ethics committee name [4]

Tasmania Health & Medical Human Research Ethics Committee (EC00337)

Ethics committee address [4]

Department of Health and Human Services
Level 2, Peacock Building
90 Davey Street
Hobart   Tas   7000

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

17/02/2015

Approval date [4]

17/03/2015

Ethics approval number [4]

Ethics committee name [5]

ACT Health Human Research Ethics Committee

Ethics committee address [5]

PO Box 11
Woden
ACT 2606

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

05/06/2015

Approval date [5]

22/07/2015

Ethics approval number [5]

ETH.6.15.105

Summary

Brief summary

Dementia was the third leading cause of death in 2010, with 9,003 deaths recorded across Australia. For people aged 65 and over, dementia was the second leading cause of burden of disease and the leading cause of disability burden. Dementia is now the ninth National Health Priority Area in Australia.
Bail et al. (personal communication) from the Hospital dementia Services Project (2012) indicates that patient with dementia in medical and surgical services have 2.5 times increased risk of adverse event compared to the no dementia group matched for age and other comorbidities.
In the acute hospital setting patients can have difficulties with memory and thinking because of dementia or for other reasons such as delirium or specific brain injury such as stroke. Irrespective of the cause, disorders of memory and thinking or more succinctly Cognitive Impairment (CI) are a source of risk in the complex hospital environment.
While dementia can also occur in younger people, the current study will focus on patients in acute hospitals aged 65 and over with cognitive impairment as this is the largest hospital group.

Rationale for study: 
It is recognised that hospital staff are not adequately equipped to identify or respond appropriately to people with dementia.
The Dementia Care in Hospitals Program (DCHP) is an all of hospital education program to improve communication with and awareness of patients with Cognitive Impairment (CI) linked to a bedside alert: the cognitive impairment identifier (CII). This program was first developed and introduced at BHS in 2004 in partnership with people with dementia and their families. The DCHP has been adopted by 25 public and private hospitals in Victoria. The program involves comprehensive training for clinical and non-clinical hospital staff. 
Unpublished evaluations of the program found that 80% of staff reported it improved their practice and 40% reported that it had improved their response to carers. Carers also reported greater satisfaction with the care their family member received (AIHW 2013). However, while staff perceptions and carer and patient satisfaction were measured, the effect of the DCHP on clinical outcomes such as adverse events and cost effectiveness has not been measured. 
The Department of Social Services has now funded a roll-out of the DCHP to other Australian jurisdictions and requested a national evaluation which is the basis for this study. There are three interrelated but separate elements to the evaluation that is the subject of this protocol-
1.	Change in patient quality of life, carer satisfaction and staff knowledge and perceived difficulty with care
2.	Change in nursing modifiable adverse events in patients over 65 with cognitive impairment
3.	Cost effectiveness of the DCHP
Element (2) is the basis for a PhD to be completed by A/Prof Mark Yates

Trial website

Trial related presentations / publications

The Dementia Care in Hospitals Program- Protocal for National Evaluation and Roll Out
Poster Presemtation
NHMRC National Institute for Dementia Reseach Symposium May 2016.
A/Prof Mark Yates 
See attachment on ANZCTR registration form

Public notes

Attachments [1]

/AnzctrAttachments/369086-Final Poster.pdf (Other)

Contacts

Principal investigator

Name

A/Prof Mark Yates

Address

Ballarat Health Services
Drummond St North
Ballarat 3350
Victoria

Country

Australia

Phone

+61 3 53203704

Fax

mark.yates@bhs.org.au

Contact person for public queries

Name

Mark Yates

Address

Ballarat Health Services
Drummond St North
Ballarat 3350
Victoria

Country

Australia

Phone

+61 3 53203704

Fax

mark.yates@bhs.org.au

Contact person for scientific queries

Name

Mark Yates

Address

Ballarat Health Services
Drummond St North
Ballarat 3350
Victoria

Country

Australia

Phone

+61 3 53203704

Fax

mark.yates@bhs.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		In 2014 the Commonwealth Department of Health fund... [More Details]
Other files	No		Protocol	369086-(Uploaded-23-11-2018-14-10-13)-Other results publication.pdf

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No additional documents have been identified.

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